JP6970084B2 - Vascular closure device - Google Patents

Description

Related Patent Application This application is based on Swedish Patent Application No. 1551238-7 and Thomas Larzon filed on September 28, 2015 under the name of the invention of "VASCULAR CLOSURE DEVICE" with Thomas Larzon as the inventor. As the inventor, claiming the interests of Swedish Patent Application No. 1551441-7 filed on November 6, 2015 under the name of the invention of "Vascular Closure Device", the whole including the full text and drawings of each patent application. , Incorporated in this application by reference.

The present disclosure relates to a vascular closure device configured for use, for example, for closure of a puncture in the artery after a percutaneous intervention procedure. The present disclosure also relates to a method of vascular closure using such a vascular closure device.

In most cardiovascular surgery, a catheter is inserted into an artery, such as the femoral artery, either directly or by percutaneous vascular access. The catheter is usually inserted directly into the artery along the guide wire (bareback procedure), or the catheter may be inserted through a vessel introducer. When the procedure is complete, the doctor removes the catheter and then (if a vessel introducer was used) removes the vessel introducer from the vessel. The physician must then prevent bleeding from vascular access or limit the amount of bleeding. Currently, many methods are used by physicians to close vascular access, including local external compression, suture closure devices, plugs, gels, foams, and more.

However, such closure procedures can be time consuming and can devote most of the surgical time. In addition, existing methods may be associated with complications such as hematoma or embolism. In addition, some of these procedures, especially closure devices with sutures, are known to be more likely to cause malfunction in the presence of common vascular diseases such as atherosclerosis and calcification. ing.

Patent Document 1 (European Patent No. 2095774 (B1)) proposes the introduction of a semi-automatic closing device in order to overcome the above-mentioned problems. The proposed closure device delivers and engages the closure element in the tissue near the opening of the body cavity. The device includes a sheath with a lumen extending from the proximal end to the distal end, and a position input member located within the sheath, the position input member further distant from the distal end of the sheath. It has a distal part that extends to the position. One or more positioning elements are provided distal to the position input member, the positioning elements being selectively expandable between a substantially axial reduction configuration and a substantially transverse expansion configuration.

Patent Document 1 reduces the burden on the patient to some extent by shortening the time required for vascular closure, but rapid vascular closure seems to have room for further improvement, especially in terms of device usability.

European Patent No. 2095774 (B1)

In view of the aforementioned and other drawbacks of the prior art, the first aspect of the present disclosure provides a vascular closure device that closes a passage through a tissue adjacent to a blood vessel. The vascular closure device has an elongated enclosure having proximal and distal ends and the distal end adjacent to the tissue, and a first and second detachable enclosure in the elongated enclosure. A deployment configured to deploy the mating member and the first and second engaging members, which are placed in an elongated housing and engage and contact the tissue at a distance from each other without engaging with the walls of the blood vessel. It comprises a member and a retracting member arranged in an elongated housing and configured to reduce the distance between the first and second engaging members in order to close the passage.

According to the present disclosure, vascular closure devices are used percutaneously at vascular access sites used for diagnostic or therapeutic intervention. In some embodiments, the vascular access site may be described as a "passageway through tissue adjacent to the blood vessel." The engaging member is placed via the vascular closure device, separated and attached to the tissue adjacent to the vessel without engaging with the wall of the vessel. The engaging member is then separated from the vessel closure device by a deploying member, eg, an extrusion rod placed within a separate lumen in the vessel closure device. In certain embodiments, the extruded assembly may be placed in a common lumen that simultaneously deploys all engaging members, for example by a spring loading mechanism or similar function. The engaging member is preferably connected to an elongated elastic tension element such as a suture. The suture may pass through each engaging member in sequence or may be connected to each engaging member separately. Then, the tissue adjacent to the blood vessel is pulled together by the suture thread connected to the engaging member. When pulled together, the distance between the initial positions where the engaging members are placed to engage the tissue is reduced, closing passages such as the vessel access sites described above. This tightening creates a tissue lock that closes the passage in the tissue adjacent to the blood vessel and indirectly closes the passage in the blood vessel / artery.

The advantages of the present disclosure are that large-diameter passages such as large-diameter access sites can be closed after the procedure, and that the access site is prepared for percutaneous closure in advance of important closure procedures such as acute cases. May not be required. However, the present disclosure is not limited to large-diameter holes, and the vascular closure device can also close small-diameter paths / holes.

In addition to the above, since it does not directly engage the blood vessel, the blood vessel is not included when closing the passage of the tissue adjacent to the blood vessel, and only the tissue adjacent to the blood vessel is used to close the passage. This may generally avoid possible incisions in the endometrium and the resulting thrombosis or complications associated with affected vessels such as calcified plaques, or may prevent puncture of the arterial wall. In addition, the proposed vascular closure device replaces traditional invasive manual surgical procedures with automated, minimally invasive, and easy-to-learn closure methods.

As used herein, the terms "proximal" and "distal" are used with reference to the clinician operating the vascular closure device. The term "proximal end" means the part closest to the clinician, and the term "distal end" means the part away from the clinician. For convenience and clarity, spatial terms such as "vertical," "horizontal," "top," and "bottom" may be used herein with respect to drawings. However, vascular closure devices may be used in many orientations and positions, and these terms are not intended to be limiting, absolute, or both.

In some embodiments, the engaging member can be configured to mechanically engage (or anchor) the tissue at a predetermined distance from the distal end of the vessel closure device. The predetermined distance may be as short as a few millimeters in some embodiments.

In certain embodiments, the first and second engaging members are configured to engage the fascia of the tissue. The fascia consists of fibrous connective tissue containing tight bundles of collagen fibers oriented in a wavy pattern. Thus, the fascia is flexible and can withstand large unidirectional tensile forces until the wavy pattern of fibers is aligned straight by the tensile force. In some embodiments, the configuration of a vascular closure device configured such that the first and second engaging members engage the fascia of the tissue further adequately improves the closure of the passage to the vessel. Conceivable. In addition, the fascial structure may allow the aforementioned distance reductions without the risk of the first and second engaging members disengaging / separating from the tissue.

In embodiments of the present disclosure, the vascular closure device further comprises an anvil member used to locate the anterior wall of the blood vessel / artery and is used to provide a reference point for the blood vessel. Such mounting may allow the first and second engaging members to properly engage the tissue at a predetermined distance from the anvil member. In a possible embodiment, the distal end of the elongated enclosure may be located, for example, a few millimeters above the fascia, usually not in contact with the fascia or the wall of the blood vessel.

In addition to providing a reference point for the engaging member, the anvil member may also be used to control bleeding during surgery. However, it should be understood that it is of course possible to include additional hemostatic members configured to stop blood flow through the fascia, blood vessels, or both passages, and the hemostatic members are first and first. 2 is placed in the blood vessel before deployment of the engaging member.

As mentioned above, the anvil member may provide a direction with respect to the blood vessel, eg, a two-dimensional direction (xy) with respect to the blood vessel. This may further facilitate the first and second engaging members to mechanically capture or secure the tissue to the blood vessel in a predetermined pattern.

The anvil member may consist of, for example, a balloon, a deployable disc, a deployable alignment mechanism or a anchoring plate, depending on the selective implementation of the vessel closure device. As a matter of course, a plurality of similar anvil members can be used. In addition, according to the present disclosure, it is also possible to remove the anvil member from the blood vessel so as to leave nothing in the artery at the stage of completing the procedure with the blood vessel closure device. The anvil member may be arranged so as to form a part of an elongated housing, for example.

Instead of using anvil members to provide a reference point for the vessel, the vessel closure device is configured to provide a small port in the distal end of the device that communicates with a lumen that extends to an external port near the proximal end of the device. May be good. Then, the operator of the blood vessel closing device visually observes the blood coming out of the proximal port after inserting the blood vessel closing device, that is, the distal port is made to enter the inside of the blood vessel and is pushed by the blood pressure to cause the blood to flow. A reference point can be determined by confirming that it has passed through the vessel closure device.

In addition, the vessel closure device may further include a device positioning member that is aligned in the longitudinal direction of the vessel prior to deploying the first and second engagement members. Such device positioning members can be mounted, for example, using stretchable portions of the housing, and the device positioning members are aligned with the limb (eg, leg or arm) in which the passage is located.

As described above, the suture can be connected to the first and second engaging members, and the retracting member is configured to retract the suture and reduce the distance between the first and second engaging members. Will be done. One suture may be connected to all engaging members, or one suture may be independent of the first engaging member and the corresponding suture may be independent of the second engaging member. May be connected. To the extent of the present disclosure, it is possible, for example, to include a third or fourth (or more) engaging member, the one or more sutures being the engaging member in the same manner as described above. It is understood that it can be connected to. Alternatively, a separate suture may be attached to each engaging member and pass through the lumen through the distal aspect of the device, thereby applying a tensile force to the suture to cause fascial deposits ( Fascia attachments) are pulled towards the vessel closure device, reducing the distance between the engaging members and closing the passage.

In some embodiments, the suture may be suitable to be formed from a biodegradable or bioabsorbable material, such as a bioabsorbable polymer. In addition, the engaging member may be made of a similar biodegradable or bioabsorbable material. This does not require additional engagement for removal of the engagement member / suture and simplifies post-treatment of the closure site.

In embodiments of the present disclosure, the vascular closure device is further configured to include a suture restraint or locking member disposed in an elongated enclosure, thereby maintaining the suture in a retracted state. Make the above-mentioned tissue locking portion. In addition, the locking member may be formed from similar biodegradable or bioabsorbable materials. If separate sutures are used for each engagement member, or if one suture makes a loop of multiple engagement members, the locking arrangement may be, for example, a wire binding a bundle of collected sutures. It may be formed by, and both ends of the suture are bundled. In addition, in one embodiment, the locking member is formed by a preloaded coil (preloaded coil) arranged to grip and fix the tightened sutures to each other in a retracted state. You may.

Therefore, when each suture is provided to each engaging member (or when both ends of one suture forming the loop described above are used), a plurality of sutures (or ends of the suture). May pass through the center of the lumen protruding distally from the main chassis of the vascular closure device. In such an embodiment, a locking member, such as a suture holding coil, is initially placed on the outer diameter of this cavity and preloaded or pre-stretched to apply the coil. When disengaged from the distal tip of the cavity, it may shrink in diameter on the suture to prevent the relative movement of two or more sutures. To deploy the suture holding coil in a timely manner, the suture holding coil slides another tube distally out of the preloaded cavity, and the outer tube pulls the coil from the inner tube. It may be pushed out so that the coil contracts on multiple sutures. The suture holding coil may consist of two or more layers of coil windings, and in another embodiment may consist of three to four layers of spiral coil windings. In a possible embodiment, the cross section of the wire constituting the coil is not a circle and may have edges or corners to increase friction with the suture.

Further, in order to provide a connection point suitable for the retracting member to reduce the distance between the engaging members, the engaging member (first and second, a larger number of engaging members, etc.) may be a fascia or the like. It may be in the form corresponding to one of a barb, a hook, a needle, an anchor, and a spear that mechanically captures the tissue including.

Alternatively, the engaging member may consist of an anchor (or be formed to provide a corresponding function), the anchor being arranged as a flexible structure. Anchors are also configured to rotate, swivel, or expand when engaged and connected to tissue, including fascia, thereby further improving mechanical capture of such anchors within the tissue in some cases. Let me. In another embodiment, the anchor can be configured to expand after being pushed into the fascia.

For example, the anchor is shaped like a folded umbrella as it passes through the fascia, and either by urging spring force or the tensile force of the suture, the anchor becomes an inverted cone like an open umbrella. Extend to configuration. Thereby, it contacts the fascia with a much larger surface area than the anchor of the original configuration and provides greater retention strength within the fascia. In addition, the engaging member may include a subcutaneous tube fragment having an oblique end, as described below in a mode for carrying out the invention of the present disclosure.

A further aspect of the disclosure provides a method of closing the passage of tissue that communicates with a blood vessel. The method comprises providing a vascular closure device. The vascular closure device includes an elongated housing having a proximal and a distal end, first and second engaging members detachably arranged in the elongated housing, and deploying members arranged in the elongated housing. It also includes a retractable member arranged in an elongated housing. When provided, the distal end of the vascular closure device is placed close to the tissue and the deploying member deploys the first and second engaging members from the vascular closure device and does not engage the walls of the vessel. They engage the tissue at a distance from each other and apply a predetermined pulling force by the pulling member to reduce the distance between the first and second engaging members and close the passage. The aspects of this disclosure provide the same advantages as described above with respect to the earlier aspects of this disclosure.

In some embodiments, the vascular closure device that closes the passage through the tissue adjacent to the blood vessel to treat the passage of the blood vessel is the proximal end, the distal end, the distal site, and each deployed. It may include an elongated enclosure with multiple engaging members configured to be secured to the tissue. A plurality of unfolding members are configured to extend radially outward from the distal portion of the elongated housing, and each unfolding member deploys at least one engaging member to a tissue adjacent to the blood vessel. It is configured to do. Thereby, the engaging members are fixed to the tissue adjacent to the blood vessel and are arranged at a distance from each other so as to engage and contact the tissue without engaging with the wall portion of the blood vessel. Each of the plurality of elongated elastic tension elements may be secured to at least one engaging member. The pull-in member is connected to work with the pulling element and exerts an axial pulling force on the pulling element to reduce the distance between the engaging members in a radial direction, closing the passage of tissue adjacent to the blood vessel. It is configured to do.

Further features and advantages of the present invention will become apparent by considering the accompanying claims and the following description. It will be appreciated by those skilled in the art that different features of the present disclosure may be combined to create embodiments other than those described below without departing from the scope of the present disclosure.

Various aspects of the present disclosure, including specific features and advantages, will be fully understood from the embodiments and accompanying drawings for carrying out the invention below.
A first embodiment of a blood vessel closure device according to an embodiment of the present disclosure is schematically illustrated. A detailed view of how to make a tissue locking part using a blood vessel closing device is shown. A detailed view of how to make a tissue locking part using a blood vessel closing device is shown. Demonstrates a series of closure procedures that treat unwanted passages through the walls of blood vessels. Demonstrates a series of closure procedures that treat unwanted passages through the walls of blood vessels. The conceptual diagram of the engaging member exemplified as an anchor element is shown. The conceptual diagram of the engaging member exemplified as an anchor element is shown. The operation of the anvil member that functions as a deployable alignment mechanism is shown. The operation of the anvil member that functions as a deployable alignment mechanism is shown. A series of operations of an embodiment of a blood vessel closure device is shown. A series of operations of an embodiment of a blood vessel closure device is shown. A series of operations of an embodiment of a blood vessel closure device is shown. A series of operations of an embodiment of a blood vessel closure device is shown. A series of operations of an embodiment of a blood vessel closure device is shown. A series of operations of an embodiment of a blood vessel closure device is shown. A series of operations of an embodiment of a blood vessel closure device is shown. A series of operations of an embodiment of a blood vessel closure device is shown. A series of operations of an embodiment of a blood vessel closure device is shown. 5A is a perspective view of the operation of the vascular closure device shown in FIGS. 5A-5I. 5A is a perspective view of the operation of the vascular closure device shown in FIGS. 5A-5I. 5A is a perspective view of the operation of the vascular closure device shown in FIGS. 5A-5I. 5A is a perspective view of the operation of the vascular closure device shown in FIGS. 5A-5I. 5A is a perspective view of the operation of the vascular closure device shown in FIGS. 5A-5I. 5A is a perspective view of the operation of the vascular closure device shown in FIGS. 5A-5I. The application of the locking member provided in the form of a preload coil arranged to grip the suture is conceptually shown. The application of the locking member provided in the form of a preload coil arranged to grip the suture is conceptually shown. The application of the locking member provided in the form of a preload coil arranged to grip the suture is conceptually shown. The operation of the additional engaging member provided as a subcutaneous tube fragment is shown. The operation of the additional engaging member provided as a subcutaneous tube fragment is shown. The operation of the additional engaging member provided as a subcutaneous tube fragment is shown. A cross section of a further embodiment of vascular closure is shown. A cross section of a further embodiment of vascular closure is shown. A cross section of a further embodiment of vascular closure is shown. It is a flow diagram which shows the step of the method of operating the blood vessel closure device which concerns on this disclosure.

The present disclosure will be more fully described below with reference to the accompanying drawings showing embodiments of the present disclosure. However, this disclosure may be implemented in many different forms and should not be construed as limited to the embodiments described herein. Rather, these embodiments are provided for completeness and completeness and are sufficient to inform those skilled in the art the scope of the present disclosure. In all drawings, similar reference symbols refer to similar elements.

In particular, referring to the drawing with reference to FIG. 1, the vascular closure device 100 is percutaneously introduced into the blood vessel / artery 5 along the guide wire 8 through the patient's skin 1 and tensor fasciae latae 2. Optionally, an anvil member 9 is placed in the blood vessel 5 to create a reference point for the engaging member 11, control bleeding, or both. The engaging member 11 is placed through the blood vessel closing device 100, separated and attached to the tissue adjacent to the blood vessel 5. The engaging member 11 may engage with the fascia 3 (iliac fascia), but does not engage with the wall 5 of the blood vessel. For example, the engaging member 11 may be extruded from the vessel closing device 100 into the fascia 3 by a deploying member such as an extruded rod 12 disposed in an independent lumen within the vessel closing device 100, eg, a common lumen. The extrusion assembly arranged in may unfold all engaging members 11 at the same time by a spring load mechanism or the like. The engaging member 11 is preferably connected to one or more sutures, as described in detail below. FIG. 1 further shows the femoral vein 4, the femoral nerve 6, and the adjacent / stromal tissue 7.

Further referring to FIGS. 2A and 2B, the suture thread 13 described above may pass through each engaging member 11 in order, for example. In particular, one suture 13 may pass through each engaging member 11 in sequence to form a loop, or separate sutures 13 may be attached to each engaging member 11. Tissues such as the fascia 3 are pulled together with the suture 13 connected to the engaging member 11. When pulled together, the tissue / fascia 3 is tightened toward the center, creating a tissue lock and indirectly closing the artery 5. That is, the distance between the initial positions of the engaging members 11 and the distance between the engaging members 11 after the engaging members 11 have moved toward each other are reduced. Upon tightening the fascia 3, the anvil member 9 may be removed from the artery 5.

Referring to FIGS. 2C and 2D, embodiments of a series of closure procedures are shown. Treatment is performed to slow or stop bleeding from the internal volume of the blood vessel (not shown) to a clinically acceptable level for the passage through the vessel wall, such as the illustrated blood vessel. As seen in FIG. 2C, passages in the vessel wall, specifically passages such as the femoral artery 5, are substantially aligned with passages through the panniculus adjacent to the lateral surface of the femoral artery 5. In this particular preferred embodiment, the panniculus on the outside of the femoral artery 5 and adjacent to the outer surface of the femoral artery 5 is the iliacus myocardium 3. In general, the phrase "nearly aligned" used in aisles means that there is no significant lateral displacement at least between tissue 3 and artery 5, and an elongated device of appropriate size, such as a catheter or sheath, is used in both aisles. May mean that you can pass through. In addition, as shown in FIG. 2D, in some cases, the tissue 3 may be gathered and approached around the tissue 3 passage so that the tissue / fascia 3 passage can be closed to form a tissue locking portion. The tissue layer 3 is sufficiently close to the outer surface of the blood vessel 5 so that it can be displaced with respect to the outer surface of the artery 5 near the passage through the artery 5 by tightening the tissue / fascia 3 collected and closed. Sometimes. When the collected tissue 3 is displaced, deflected and placed in a position corresponding to the artery 5 passage and the artery 5 wall around the artery 5 passage, it is clinically acceptable from the artery 5 passage. This mechanical approach is usually sufficient to slow or stop bleeding, allowing closure of the access site through the patient's skin 1 near the passage. In some cases, in the area where each passage is located, the inner surface of the panniculus 3 adjacent to the outer surface of the blood vessel 5 is separated from the outer surface of the blood vessel by a distance of up to about 10 mm, more specifically about 5 mm. There may be.

Further referring to FIGS. 3A and 3B, the engaging member exemplified as the anchor element 300 is conceptually shown. FIG. 3A shows the initial deployment of the anchor element 300 so that it can be easily slid away from the deployment point. In addition, in order to promote engagement, the deployment point may be arbitrarily biased in the direction of the tissue / fascia 3. FIG. 3B shows the anchor element 300 after the movement is reversed in the direction of the deployment point, and the anchor element 300 is embedded in the tissue / fascia 3. That is, in one embodiment, the tip 302 of the anchor element 300 is hook-shaped and easily slides outward without engaging with the tissue / fascia 3. However, when the anchor element 300 is retracted, at least the tip 302 of the anchor element 300 is configured to mechanically engage the tissue / fascia 3.

4A and 4B conceptually show the operation of an anvil member exemplified as the deployable alignment mechanism 400. In FIG. 4A, a deployable alignment mechanism 400 is inserted through the wall 402 into the internal volume of a blood vessel such as the femoral artery 5. The deployable alignment mechanism 400 has an umbrella-like structure (using a mesh material), and the deployable alignment mechanism 400 may be inserted into the artery 5 in a radial folded manner. Further referring to FIG. 4B, upon entering the artery 5, the deployable alignment mechanism 400 "opens", expands radially from the folded form and approaches the deployable alignment mechanism 400 in the longitudinal direction. The total surface area increases and may be drawn toward the inner wall of the artery 5. This establishes a reference point for subsequent operation of the vessel closure device.

5A-5I, together with FIG. 10, will explain the procedure for using the blood vessel closing device 500 according to the second embodiment of the present disclosure step by step. As shown in FIG. 5A, the vascular closure device 500 is provided in the first step (S1). In deployment, the vessel closure device 500 was, for example, already inserted until the conical distal tip 502 (which may also provide a conical nose cone) of the elongated enclosure 504 of the vessel closure device 500 was placed. It is advanced along the guide wire 8 (S2). Next, as shown in FIG. 5B, the extrusion rod is ejected from the housing close to the fascia 3 at the upper part of the outer surface of the wall of the artery 5. Optionally, the vascular closure device 500 is aligned by approximately aligning the longitudinal markings of the vascular closure device 500 (discussed below in connection with FIGS. 9A-9C) along the longitudinal axis of the patient's common femoral artery 5. May be.

In this embodiment, one suture thread 13 for each engaging member 11 first exits the distal tip through the center of the vessel closure device 500 and rises along the outer surface of the vessel closure device 500. It leads into the slot of the elongated housing 500 that accommodates the engaging member 11 before unfolding. Then, when the engaging member 11 is unfolded as shown in FIG. 5C (S3), it rises from the distal tip 502 of the vascular closure device 500 and rises from the (existing existing) fascia 3 as shown in FIG. 5D. ) The pull-in member pulls the suture thread 13 that passes through the hole and leads outward to the position of the engaging member 11.

When a tensile force is applied by the pull-in member (S4) and the direction is reversed, the engaging member 11 mechanically engages the tissue / fascia 3 as shown in FIG. 5E and the extrusion rod 12 (deployment). The member) withdraws into a slot, a hole, or a lumen in the elongated housing 504 of the vascular closure device 500 from which it is deployed.

At this stage, a plurality of engaging members 11 (eg, 4 or any other number of engaging members, the number of engaging members may be an odd number) are present on each side of the common femoral artery 5 to the tissue / fascia 3 It is embedded and fixed in the tissue / fascia 3 at various places around the passage that is closed inside. In some cases, the engaging member 11 may be symmetrically arranged on both the medial and lateral sides of the common femoral artery 5. A suture 13 is connected to each engaging member 11, and the suture 13 passes down the hole in the fascia 3 from the anchor and leads into the distal tip 502 of the blood vessel closure device 500.

An initial tensile force is then applied to the suture, pulling the engaging member 11 (and fascia 3) towards the vessel closing device 500. Here, as shown in FIG. 5F, the blood vessel closing device 500 is slowly pulled out until the distal tip 502 is located in the fascia layer 3 or the upper part of the fascia layer 3, and the engaging members 11 are collectively closed. The tensile force of the suture 13 is maintained to continue pulling towards the distal tip 502 of the device 500, thereby pulling all engaging members 11 towards one point and closing the passage.

At this point, as shown in FIG. 5G, locking members such as a fixation ring 508 and a sleeve through which each suture 13 passes are deployed from the distal tip 502 of the vessel closure device 500. The fixation ring 508 compresses a bundle of sutures 13 to lock the sutures in place, preventing the fascia 3 and passages from reopening and indirectly closing the artery 5. Further, when the expected degree of hemostasis is achieved, the guide wire 8 may be removed while maintaining the tensile force of the suture 13. The guide wire 8 may, for example, pass through the side surface of the fixing ring 508 rather than inside the fixing ring 508. This may allow the suture 13 to be fully retracted and the fixation ring 508 to be deployed to lock the suture 13 in place without removing the guide wire 8.

The fixation ring 508 is spring-like and may be held open on the blood vessel closing device 500 and automatically closed on the suture thread 13 after being deployed from the blood vessel closing device 500. Alternatively, this locking ring function may be performed by another suture loop that is pre-knotted, where the knot is fastened and secured with other sutures attached to the anchor. In yet another embodiment, the fixation ring 508 may be a fusion mechanism that uses heat and / or pressure to fuse the sutures together. In yet another embodiment, the fixation ring may be a small tube through which the suture is initially slidable, which is compressed by a mechanism within the housing to trap and secure the suture.

Since the passage has been closed as shown in FIG. 5H, the removal of the vessel closing device 500 may continue at this stage. If desired, once the suture 13 is secured in place, the mechanism within the vessel closing device 500 handle may be activated to cut the suture just above the fixation ring / region. Alternatively, as shown in FIG. 5I, the suture 13 may be left at this stage and cut off on the skin surface by the operator. In this way, the vascular closure device 500 is completely removed.

Figures from another perspective of the present disclosure are shown in FIGS. 6A-6F. Note that in FIGS. 6A and 6B, the fascia 3 is omitted for clarity in these drawings. In FIG. 6A, the vessel closure device 500 guides the vessel until the tapered distal tip 502 is placed so that the deploying member (eg, the extrusion rod 12) exits the enclosure adjacent to the fascial layer above the artery 5. Advance along 8. In FIG. 6B, the engaging member 11 is unfolded from the elongated housing 504 of the vessel closure device 500 and pulls together a pre-tethered suture 13 passing through the distal tip 502 of the vessel closure device 500. In FIG. 6C, the pull-in member reverses the direction of movement (details will be described later), and the engaging member 11 is embedded in the tissue / fascia 3, for example, around a passage 602 passing through the tissue / fascia 3. Is embedded in a predetermined pattern. Then, the engaging member 11 is separated from the deploying member. In FIG. 6D, the engaging member 11 is placed in place with the suture thread 13 connected, and the deploying member (eg, the extrusion rod 12) is pulled in with a predetermined pulling force. In FIG. 6E, the vascular closure device 500 is partially withdrawn until the distal tip 502 is directly above the fascia 3, thereby exerting a tensile force on the suture and pulling the engaging member 11 together. The passage 602 is closed so as to reduce the diameter of the passage 602. In FIG. 6F, the suture 13 is fixed and the blood vessel closing device 500 is pulled out.

If desired, a hemostatic member (not specified in the drawings) may be added to the distal tip 502 of the vessel closure device 500. When the blood vessel closing device 500 advances and contacts the fascia 3, the hemostatic member is first placed in the artery 5, and during use of the blood vessel closing device 500, the hemostatic device is activated to prevent bleeding from the artery 5. do. Since the engaging member 11 is pulled when the blood vessel closing device 500 is initially retracted, the hemostatic member may stop operating and be pulled out. An example of a hemostatic member is an inflatable elastic balloon. In addition, a hollow lumen may optionally be left in the center of the elongated enclosure 506 and a dilator or cannula may be placed through the lumen to facilitate initial insertion of the vessel closure device 500. This dilator helps maintain hemostasis and may be slowly removed when the suture 13 is squeezed.

7A-7C provide a detailed view of the application of a locking member or fixing ring, which is provided here in the form of a preloaded locking coil 508 arranged to grip the suture 13. FIG. 7A shows the locking coil 508 in the initial position, which extends onto the outer surface of the lumen extending from the distal end that is part of the housing 504. The suture 13 passes through this lumen and is connected to each engaging member 11 deployed to engage the tissue / fascia 3. In FIG. 7B, a pull-in member (eg, implemented using the pull-in force applying mechanism described above) is used to apply a tensile force to the suture 13, resulting in a reduction in the distance between the engaging members 13, thereby reducing the distance between the engaging members 13. Close the tissue / fascia 3 passage 602. The suture holding coil 508 is extruded from the above-mentioned lumen, contracts to grab and fix the suture 13, and holds the engaging members 11 in positions adjacent to each other. In FIG. 7C, the vessel closing device 500 is pulled out and the locking coil 508 holds the engaging members 11 in close proximity to each other. This allows all tensile forces to be released from the suture 13 to prepare for complete removal of the vessel closure device 500, cutting of the suture just below the skin, and completion of the closure procedure.

8A-8C show the operation of the engaging member 11 provided as a tubular element with one end oblique or cut. Tubular elements may be formed, for example, from subcutaneous tube fragment 800. In FIG. 8A, the subcutaneous tube 800 mounted on the tip of the deploying member is shown. In FIG. 8A, the subcutaneous tube 800 is arranged on the extrusion rod 12, and the suture thread 13 is attached to a position within the central portion of the subcutaneous tube 800. The acute angle / cross-sectional end of the subcutaneous tube 800 is where it pierces the fascia 3. In FIG. 8B, the subcutaneous tube 800 penetrates the fascia 3 and the extrusion rod 12 is pulled back, leaving only the subcutaneous tube 800 and the suture 13 attached to the subcutaneous tube 800 in place. A tensile force is applied to the suture thread 13. Since the suture thread 13 is attached to the central portion of one side of the subcutaneous tube 800, the subcutaneous tube 800 is rotated by approximately 90 ° when it is hooked on the lower side of the fascia 3. In FIG. 8C, as the rotation is completed and the tensile force of the suture 13 increases, the subcutaneous tube 800 comes into complete contact with the fascia 3 along the longitudinal direction of the subcutaneous tube 800. This widens the contact area and makes it difficult for the subcutaneous tube 800 to be pulled back from the fascia 3 through the hole created when it first penetrated the fascia 3 by simply pulling it. In some cases, as shown in FIG. 8C, it can be said that the subcutaneous tube 800 is mechanically captured by the fascia 3 when the rotation is completed and the subcutaneous tube 800 is in complete contact with the fascia.

9A-9C show cross sections of a further embodiment of the vascular occluder 900. FIG. 9A shows the initial configuration of the device. The extruded rod 12, ie the engaging member and suture 13, is housed within the device (not specified in FIG. 9A). FIG. 9A shows a thumb button 902 that has not yet been pressed, with the base coil spring 904 in the extended position. The engaging member 11 is in the initial position and is housed in the distal end 906 of the housing at the distal end of the engaging member 11. The blood vessel closure device 900 further comprises a device positioning member in the shape of an elongated handle 908 that is aligned in the assumed direction of the blood vessel.

FIG. 9B shows the vascular closure device 900 after the engagement member 11 has been deployed. When the thumb button 902 is pressed, the winding spring 904 at the base is compressed and the upper clip 910 is engaged and held in place. The extrusion rod 12 is in the extended position and the engaging member 11 is still attached to the distal tip. FIG. 9C shows the vessel closing device 900 in the completed state, the locking clip 910 is released, and the winding spring 904 returns to the initial position direction. Upon returning to the initial position, a pulling force is applied (by a pulling member not specified) and the suture 13 is "pulled" back into the vessel closing device 900. As described above, when the suture 13 is pulled back to the vessel closing device 900, the distance between the engaging members 11 is reduced, resulting in a reduction in the diameter of the passage through the tissue / fascia 3 and indirectly tissue locking. Make a part. When the suture is fully retracted (by a predetermined pulling force applied by the winding spring 904), a locking member such as the locking ring 508 is arranged to secure the suture 13 in the retracted state.

The above description of the vascular closure device has focused on the initially envisioned usage of closing vascular access, but some embodiments where this initially envisioned usage does not provide clinically acceptable hemostasis. In order to improve hemostasis to clinically acceptable levels, one or more vascular closure devices described herein are additionally used to introduce additional engagement members for tissue access. Further assistance may be provided.

Even if the drawings are shown in sequence, the order of each step may differ from that shown. In particular, the characteristics of the anchor hook are shown much larger than they really are for the sake of explanation. In addition, two or more steps may be performed simultaneously or partially simultaneously. Such variants depend on the components used and the designer's choice. All such modifications are within the scope of the present disclosure. In addition, although the present disclosure has been described with reference to specific exemplary embodiments, many changes, amendments, etc. will be apparent to those of skill in the art. In addition, the features, dimensions or materials suitable for any particular vascular closure device embodiment described herein are any of the other vascular closure device embodiments described herein. It may be used together with or in combination with the blood vessels.

Further, variations of the disclosed embodiments can be understood and implemented by those skilled in the art who implement the present disclosure by reviewing the drawings, the specification, and the accompanying claims. Furthermore, the terms "prepared" and "included" in the claims do not exclude other elements or steps, and the singular (indefinite article "a" or "an") does not exclude multiple cases.

Claims (2)

A vascular closure device that closes the passage through tissues adjacent to blood vessels.
An elongated enclosure having a proximal end and a distal end, wherein the distal end is configured to be close to the tissue.
The first engaging member and the second engaging member housed in the elongated housing,
Deployment arranged in the elongated housing and configured to deploy the first and second engaging members so as to engage and contact the tissue at a distance from each other without engaging with the wall of the blood vessel. Members and
It is provided with a retracting member which is arranged in the elongated housing and is configured to reduce the distance between the first and second engaging members in order to close the passage.
Further provided with a suture and another corresponding suture that independently connect to the first and second engaging members, respectively.
The pull-in member is configured to pull in the suture and another corresponding suture to reduce the distance between the first and second engaging members.
Vascular closure device. A vascular closure device that closes the passage through tissues adjacent to blood vessels.
An elongated enclosure having a proximal end and a distal end, wherein the distal end is configured to be close to the tissue.
The first engaging member and the second engaging member housed in the elongated housing,
Deployment arranged in the elongated housing and configured to deploy the first and second engaging members so as to engage and contact the tissue at a distance from each other without engaging with the wall of the blood vessel. Members and
It is provided with a retracting member which is arranged in the elongated housing and is configured to reduce the distance between the first and second engaging members in order to close the passage.
Further provided with sutures connected to the first and second engaging members,
The retracting member is configured to retract the suture and reduce the distance between the first and second engaging members.
Vascular closure device.

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